Neoadjuvant Chemotherapy With Pyrotinib, Epirubicin and Cyclophosphamide Followed by Taxanes and Trastuzumab for HER-2+ Breast Cancer
Primary Purpose
Breast Cancer
Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Pyrotinib
Epirubicin
Cyclophosphamide
Taxanes
Trastuzumab
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer
Eligibility Criteria
Inclusion Criteria:
- Female breast cancer patients at the age of >= 18 years and <= 65 years who received first treatment;
- Pathologically confirmed HER2-positive invasive breast cancer(which is defined as the immunohistochemistry score of > 10% immunoreactive cells being 3+ or in situ hybridization results showing HER2 gene amplification),regardless of hormone receptor status (ER and PR);
- According to the 2019 CSCO BC guidelines: When HER-2 positive is used as the standard for preoperative neoadjuvant therapy for breast cancer, the tumor is larger than 2 cm;
- The Eastern Tumor Collaborative Group (ECOG) has a physical status score of ≤1;
- The functional level of the main organs must meet the following requirements : 1) blood routine test: hemoglobin (Hb) ≥ 90g/L;Neutrophils (ANC) ≥ 1.5 × 10^9/L; platelet count (PLT) ≥ 90 × 10^9/L; 2) Blood biochemistry: Total bilirubin (TBIL) ≤ 1.5 upper limit of normal value (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 1.5 × ULN; alkaline phosphatase ≤ 2.5 × ULN; Urea nitrogen (BUN) and creatinine (Cr) ≤ 1.5 × ULN; 3) Heart color ultrasound: Left ventricular ejection fraction (LVEF) ≥ 55%;
- Women of childbearing age, tested negative for serum pregnancy test 7 days before randomization,and willing to use appropriate methods during the trial and within 8 weeks after the last administration of the test drug;
- A volunteer to participate in the study; provision of written informed consent; good compliance and willing to cooperate during the follow-up.
Exclusion Criteria:
- Known history of hypersensitivity to pyrotinib or any of it components;
- Patients have previously received antitumor treatment or radiation therapy for any malignant tumor (except for cervical carcinoma in situ and basal cell carcinoma that have been cured);
- Patients underwent major breast cancer-free surgery within 4 weeks and have not fully recovered;
- Subjects that are unable to swallow tablets,intestinal obstruction or dysfunction of gastrointestinal absorption;
- Patients with severe heart disease or discomfort who cannot be treated;
- The patient suffers from mental illness or psychotropic substance abuse and cannot cooperate;
- Pregnant or lactating women;
- Less than 4 weeks from the last clinical trial;
- Patients participating in other clinical trials at the same time
- The researchers think inappropriate.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental group
Control group
Arm Description
Patients will receive the test drug (Pyrotinib) combined with Epirubicin and Cyclophosphamide followed by Taxanes and Trastuzumab
Patients will only receive Epirubicin and Cyclophosphamide followed by Taxanes and Trastuzumab
Outcomes
Primary Outcome Measures
Pathological Complete Response rate(pCR)
pathological complete response
Secondary Outcome Measures
Objective Response Rate(ORR)
Baseline to measured stable disease
Event Free Survival(EFS)
Baseline to the occurrence of any event
Disease-free survival(DFS) Baseline to measured date of recurrence or death from any cause
Baseline to measured date of recurrence or death from any cause
Overall survival (OS)
Baseline to measured date of death from any cause
Full Information
NCT ID
NCT04290793
First Posted
February 27, 2020
Last Updated
February 27, 2020
Sponsor
Hebei Medical University Fourth Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04290793
Brief Title
Neoadjuvant Chemotherapy With Pyrotinib, Epirubicin and Cyclophosphamide Followed by Taxanes and Trastuzumab for HER-2+ Breast Cancer
Official Title
Neoadjuvant Chemotherapy With Pyrotinib, Epirubicin and Cyclophosphamide Followed by Taxanes and Trastuzumab for HER2+Breast Cancer: a Multicenter, Randomized, Open-label, Parallel-Group Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 1, 2020 (Anticipated)
Primary Completion Date
March 1, 2022 (Anticipated)
Study Completion Date
March 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hebei Medical University Fourth Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This is a prospective, open label, parallel controlled study to evaluate the efficacy and safety of neoadjuvant pyrotinib in HER2+ breast cancer patients
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
280 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Patients will receive the test drug (Pyrotinib) combined with Epirubicin and Cyclophosphamide followed by Taxanes and Trastuzumab
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Patients will only receive Epirubicin and Cyclophosphamide followed by Taxanes and Trastuzumab
Intervention Type
Drug
Intervention Name(s)
Pyrotinib
Intervention Description
400mg administered as continuous oral once daily from the first day of the study
Intervention Type
Drug
Intervention Name(s)
Epirubicin
Intervention Description
90mg/m^2 d1 iv Q2W for 4 cycles
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Description
600 mg/m^2 d1 iv Q2W for 4 cycles
Intervention Type
Drug
Intervention Name(s)
Taxanes
Intervention Description
Albumin paclitaxel(125mg/m2 d1、8 iv Q3W for 4 Cycles)/Docetaxel(100mg/m2 d1 iv Q3W for 4 Cycles )
Intervention Type
Biological
Intervention Name(s)
Trastuzumab
Intervention Description
the first cycle is a loading dose of 8 mg / kg, followed by 6 mg / kg. Iv Q3W for 1 year
Primary Outcome Measure Information:
Title
Pathological Complete Response rate(pCR)
Description
pathological complete response
Time Frame
within 3 weeks after surgery
Secondary Outcome Measure Information:
Title
Objective Response Rate(ORR)
Description
Baseline to measured stable disease
Time Frame
2 years
Title
Event Free Survival(EFS)
Description
Baseline to the occurrence of any event
Time Frame
3 years
Title
Disease-free survival(DFS) Baseline to measured date of recurrence or death from any cause
Description
Baseline to measured date of recurrence or death from any cause
Time Frame
3 years
Title
Overall survival (OS)
Description
Baseline to measured date of death from any cause
Time Frame
5 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Female breast cancer patients at the age of >= 18 years and <= 65 years who received first treatment;
Pathologically confirmed HER2-positive invasive breast cancer(which is defined as the immunohistochemistry score of > 10% immunoreactive cells being 3+ or in situ hybridization results showing HER2 gene amplification),regardless of hormone receptor status (ER and PR);
According to the 2019 CSCO BC guidelines: When HER-2 positive is used as the standard for preoperative neoadjuvant therapy for breast cancer, the tumor is larger than 2 cm;
The Eastern Tumor Collaborative Group (ECOG) has a physical status score of ≤1;
The functional level of the main organs must meet the following requirements : 1) blood routine test: hemoglobin (Hb) ≥ 90g/L;Neutrophils (ANC) ≥ 1.5 × 10^9/L; platelet count (PLT) ≥ 90 × 10^9/L; 2) Blood biochemistry: Total bilirubin (TBIL) ≤ 1.5 upper limit of normal value (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 1.5 × ULN; alkaline phosphatase ≤ 2.5 × ULN; Urea nitrogen (BUN) and creatinine (Cr) ≤ 1.5 × ULN; 3) Heart color ultrasound: Left ventricular ejection fraction (LVEF) ≥ 55%;
Women of childbearing age, tested negative for serum pregnancy test 7 days before randomization,and willing to use appropriate methods during the trial and within 8 weeks after the last administration of the test drug;
A volunteer to participate in the study; provision of written informed consent; good compliance and willing to cooperate during the follow-up.
Exclusion Criteria:
Known history of hypersensitivity to pyrotinib or any of it components;
Patients have previously received antitumor treatment or radiation therapy for any malignant tumor (except for cervical carcinoma in situ and basal cell carcinoma that have been cured);
Patients underwent major breast cancer-free surgery within 4 weeks and have not fully recovered;
Subjects that are unable to swallow tablets,intestinal obstruction or dysfunction of gastrointestinal absorption;
Patients with severe heart disease or discomfort who cannot be treated;
The patient suffers from mental illness or psychotropic substance abuse and cannot cooperate;
Pregnant or lactating women;
Less than 4 weeks from the last clinical trial;
Patients participating in other clinical trials at the same time
The researchers think inappropriate.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
YUNJIANG LIU, PHD.
Phone
86095588
Email
lyj818326@126.com
12. IPD Sharing Statement
Learn more about this trial
Neoadjuvant Chemotherapy With Pyrotinib, Epirubicin and Cyclophosphamide Followed by Taxanes and Trastuzumab for HER-2+ Breast Cancer
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